Managing knee pain with simple analgesia: the efficacy, cost and adherence implications

ISRCTN	ISRCTN87954265
DOI	https://doi.org/10.1186/ISRCTN87954265
Secondary identifying numbers	G9900285

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Alison Carr
Scientific

Academic Rheumatology
University of Nottingham
Clinical Sciences Building
Nottingham
NG5 1PB
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	1. Treatment trial: to test the hypothesis that continuous use of simple analgesia in osteoarthritis (OA) knee is more effective in reducing pain in the affected joint than analgesia used on an 'as required' basis. 2. Adherence trial: to test the hypothesis that a simple intervention delivered by practice nurses can increase adherence to continuous analgesia.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Osteoarthritis of the knee
Intervention	Treatment trial: 1. Continuous use paracetamol (4 g daily) 2. 'As required' paracetamol (up to 4 g daily as needed) Adherence trial (all patients in treatment group 1): 1. Individualised educational intervention to promote adherence delivered by practice nurse 2. No intervention
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Paracetamol
Primary outcome measure	Treatment trial: pain in the affected joint measured by 100 mm visual analogue scale Adherence trial: Proportion of patients who adhere to the regimen for continuous paracetamol
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/1999
Completion date	01/03/2002

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	244 - Discontinued after March 2002
Key inclusion criteria	1. Male and female patients over 55 years 2. Clinical diagnosis osteoarthritis of the knee 3. Current joint pain score greater than 30 on a 10 mm visual analogue scale
Key exclusion criteria	1. Serious concomitant illness 2. Other pain-related conditions 3. Abnormal liver function tests 4. History of analgesic abuse or overdose 5. Severe OA awaiting joint replacement 6. Psychological disorders requiring treatment 7. Patients unable to follow instructions/complete questionnaires. 8. Use of over the counter medication containing paracetamol for duration of the study
Date of first enrolment	01/09/1999
Date of final enrolment	01/03/2002

Academic Rheumatology

Nottingham
NG5 1PB
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan